1. Field of the Invention
The present invention relates generally to medical procedures and particularly to a method for dispensing antioxidant vitamins as a therapeutic treatment of diseases of the respiratory tract.
2. Description of the Prior Art
The assimilation of an adequate quantity of physiologically important antioxidant vitamins are essential to the health of people. Failure of the body to assimilate the necessary amount of such antioxidant vitamins which prevent free radicals to damage the body functions can lead to improper functioning of the metabolic processes, as well as to a variety of diseases and associated symptoms. For example, deficiency of betacarotene increases susceptibility to microbial infections, xerophthalmia and other eye disorders, loss of appetite and weight, sterility, abnormalities of nerve and epithelial connective tissue and of bones.
Deficiency of vitamin C can cause a breakdown of intercellular collagen substance, bleeding, petechide, fragility of the walls of capillaries, brittle bones which cease to grow, keratoconjunctivitis sicca, xerostomia, salivary gland enlargement, xerosis, hyperpigmentation, ictyosis, neuropathies and mental depression. While antioxidant vitamin deficiencies are often associated with improper dietary intake, they are also likely to be the result of malabsorption when administered by the oral route.
Vitamin C, vitamin E, and betacarotene are the most important antioxidant vitamins, which gobble the free radicals generated by pollution, cigarette smoke, sun ultraviolet rays, pesticides and other contaminants in food, water, etc. In the following description of this invention, they will be collectively termed as antioxidant vitamins.
Drugs may be administered by different methods. The various methods include oral, rectal, sublingual or buceal, parental inhalation, topical, etc. The choice of method depends upon both convenience and necessity. Obviously, drug substances are most frequently administered orally for access to the systemic circulation by means of solid dosage forms, such as tablets and capsules. Oral administration does not always give rise to sufficiently high plasma concentrations to be effective. Some drugs are absorbed unpredictably or erratically. Patients occasionally have an absorption malfunction.
Fillers and binders comprise the bulk of the contents in vitamin tablets to which most people exhibit adverse side effects, such as headaches, rashes, hives, itching, and upset stomach, while the same vitamin doses when taken as the pure vitamin by injection without fillers or binders does not produce these side effects.
Several doctors who use vitamins in their practice, have observed many such undesirable reactions, including headache, arthritis, joint pain, chronic fatigue, depression, personality changes, gout attacks, and even chronic earaches and infection in children. It has been discovered that the allergic reactions are generally to table fillers and binders, not to the vitamins themselves (though it is recognized that pure vitamins can cause problems in excessive doses).
In clinical research, it has been confirmed that 8 to 10 percent of the tested, clinical population is allergic to corn starch and other corn products and about another 10 percent to soy products. These allergies can be sufficiently severe to produce very unpleasant symptoms when vitamin tablets using these fillers and binders are taken.
Unfortunately, we live in a world that is full of hostile forces, able to trigger the release of too many free radicals in our body. Some of the agents that actively contribute to the development are air pollution, asbestos, cigarette smoke, certain anti-cancer drugs, emotional stress, joint and tissue injuries, pesticides, drinking water, chemical contaminants, radiation, reperfusion injuries, ultraviolet light, etc.
When such factors trigger the release of too many radicals, the consequence can be disastrous. To acquire full protection, it is may be necessary to fortify the body with powerful antioxidant vitamins. The latest scientific findings from all over the world confirm the potential of the antioxidant vitamins to provide health benefits which may include the following:
increased protection from many forms of cancer; PA1 stronger defenses against cardiovascular disease, such as atherosclerosis, heart attacks, and strokes; PA1 the preservation of one's eyesight through the prevention of cataracts; PA1 a delay in the onset of premature aging; PA1 a more powerful immune system; PA1 a decreased risk of early Parkinson's disease and other chronic diseases, as well as a host of other major health advantages. PA1 1. Carcinogens and co-carcinogens are present in the tar. Carcinogens (principally polycyclic aromatic alcohols) initiate cancer formation. Co-carcinogens (including phenols, fatty acids, and free fatty acids) accelerate the production of cancer by other initiators. Many co-carcinogens are also irritants. PA1 2. Irritants cause immediate coughing and bronchoconstriction after smoke inhalation, inhibit cilial action in the bronchial epithelium, stimulate bronchial mucous secretion, suppress protease inhibition, and impair alveolar macrophage function. PA1 3. Nicotine principally affects the nervous system and is probably responsible for a smoker's pharmacologic dependence on cigarettes. Nicotine indirectly affects circulation by provoking catecholamine release which causes tachycardia, increased cardiac output, vasoconstriction, and increased PB. Nicotine also increases serum free fatty acids and platelet adhesiveness, and inhibits pancreatic bicarbonate secretion. PA1 4. Toxic gases in cigarette smoke include CO, hydrogen sulfide, hydrocyanic acid, and oxides of nitrogen. The average carboxyhemoglobin level in people smoking one pack per day is about 5 percent compared to less than 1 percent in nonsmokers. This reduces the amount of Hb available of transport and shifts to the left the Hb-dissociation curve, impairing release to the tissues. PA1 1. Lung cancer. Squamous cell and small (oat) cell lung carcinomas are associated with smoking. Epidemiologic studies have shown that men who smoke more than one pack per day are about 20 times more at risk of developing lung cancer than are nonsmokers. Laboratory experiments show that tobacco smoke condensate can produce skin cancer in animals and that animals inhaling cigarette smoke may develop cancer of the larynx or lung. PA1 2. Chronic bronchitis and emphysema deaths are also about 20 times more frequent in people who smoke heavily. Both diseases can be produced in animals exposed to cigarette smoke. Pulmonary function tests often show airflow obstruction in the small airways even before chronic expectoration develops. The adverse effect of smoking on mucociliary clearance and on the normal balance between lung proteases and their inhibitors predisposes smokers to bronchopulmonary infection and emphysema. PA1 3. Cardiovascular diseases: Cigarette smoking accelerates atherosclerosis and may double the risk of myocardial infarction. Smoking may precipitate an anginal attack or ischemic ECG changes in patients with coronary artery disease. The risk of developing cerebrovascular disease, peripheral vascular disease, or non-cephalic aortic aneurysm is also increased in smokers. PA1 4. Pregnancy: The mean birth weight of infants born to mothers who smoke during pregnancy is 6 oz. less than that of infants born to nonsmoking mothers. The incidence of spontaneous abortion, stillbirth, and neonatal death may also be increased in pregnant women who smoke. PA1 5. Extrapulmonary cancers associated with cigarette smoking include cancer of the mouth, pharynx, larynx, esophagus, bladder, and pancreas. PA1 6. Peptic (especially gastric) ulceration occurs more frequently and has a higher mortality rate in cigarette smokers than in non-smokers. In addition, the effectiveness of medical treatment for peptic ulceration is reduced and the rate of ulcer healing is slowed. PA1 7. Other conditions: Pulmonary TB is more common in smokers, perhaps due to activation of old tuberculosis foci. Tobacco amblyopia may be caused by optic nerve damage due to the toxic action of cyanides in cigarette smoke in smokers with vitamin deficiency. PA1 cause a drop in the number of T-cells, which are required to kill any cancer cells that may arise; PA1 result in lower levels of antibody production (normal antibody responses are necessary for healthier immunity); PA1 enhance the ability of a carcinogen in tobacco, benzo(a)pyrene, to bind to lung cells, increasing the possibility of cancer; PA1 cause abnormal changes in epithelial tissues (those that line the inner and outer surfaces of the body and its organs). PA1 Betacarotene--25,000-50,000 International Units=15/30 mg. PA1 Vitamin C--500-1,000 mg. PA1 Vitamin E Acetate--400-800 I.U.=400/800 mg.
Many physicians have been taking antioxidant vitamins for years, even before the weight of scientific authority shifted so heavily in the antioxidant direction.
The new paradigm in health promotion is to prevent chronic disease through lifetime health habits, including daily intakes of antioxidant vitamins. Cancer has a long latency period, and it has been estimated that the interval between the initiation of lung cancer and its eventual diagnosis is in the range of 8 to 20 years. Important studies that further solidity the connections between cancer, free radicals, and antioxidant vitamins continue to proliferate.
Cigarette smoking is known to alter components of the body's immune systems. When the body is invaded by a substance that it recognizes as "foreign," the body's immune system reacts by creating antibodies to attack the foreign substance. This response may occur locally (at a specific organ site) or systematically (throughout the body).
The body's respiratory system has a well-defined local defense system. First, there are two ciliated cells with tiny hairs that line the respiratory system. The cilia prevent accumulation of inhaled matter in the lungs by transporting the particles away from the lungs. If the cilia are rendered ineffective by smoke or other irritants, cells called macrophages take up their work by engulfing and digesting hazardous substance such as bacteria.
Experiments have been able to demonstrate clearly a decrease of the cilia action due to cigarette smoking. It has been determined that smokers have more macrophages in their lungs than nonsmokers, which may indicate the irritation of the cilia, perhaps in response to the toxic ingredients of cigarette smoke.
Studies of systemic immunological responses have shown that cigarette smoking may decrease the body's production of antibodies, thus increasing its susceptibility to infection. The influence of flu-like illness has been shown to be greater among smokers of more than half a pack a day than among nonsmokers. In addition, pregnant women who smoke have more urinary tract infections than those who do not smoke.
Although the mortality risk for people who stop smoking declines, even 15 years later it is higher than in people who had never smoked. Success in response to public health education is more likely in professional and managerial people and in those best able to understand the risks associated with smoking. Unfortunately, most smokers do not usually stop smoking until the onset of ill health.
The gaseous components found in fresh smoke of medical importance may be separated as follows:
The diseases related to smoking are the following:
It has been estimated by the U.S. Surgeon General that in the U.S. alone, about 500,000 deaths are caused each year by diseases related to tobacco smoking. In fact, excessive smoking is now recognized as one of the major health problems throughout the world. The most important risk factors, however, are toxic substances which are formed during the combustion of tobacco, such as carbon monoxide, tar products, aldehydes, hydrocyanic acid, etc. Nearly 1,000 constituents of tobacco smoke have been identified; many are irritants, toxic gases, or carcinogens. These particles are inhales into the lungs, where they irritate the respiratory passages and increase the production of bronchial mucous, possibly initiating cancer.
Recent discoveries about vitamin substances have caused great optimism in the search for allies in the fight against cancer, the most important, and particularly effective for the prevention and/or treatment of smoke related diseases are the antioxidant vitamins.
Antioxidant vitamins offer some protection against lung cancer and cancer of the esophagus. They may also help ward off colon, rectal, bladder, prostate, breast, cervical, larynx, gastrointestinal, and skin cancers, among others. The evidence to support these claims comes from worldwide studies of populations with diets full of food rich in vitamin C, vitamin E, and betacarotene, as well as from laboratory studies of the vitamins, ability to prevent cancers in experimental animals.
Antioxidant vitamins appear to have such powerful anticancer effects that the cancer establishment has started clinical trials for its use in the treatment of cancer, as well as for its prevention. Such prevention seems to be particularly effective in the case of bronchogenic squamous carcinoma, since the latter has a long latency period during which metaplasia slowly develops.
Surveys conducted in the U.S. and several European Universities revealed that smokers with diets deficient in antioxidant vitamins had twice as much lung cancer as smokers whose antioxidant vitamins intake was not deficient. At first, these patients were treated with high doses of antioxidant vitamins, but they suffered from side effects of this therapy before any effect on their cancer could be documented. When researchers started experimenting with betacarotene and retinoic acid derivatives, they found these compounds to be stronger and less toxic for cancer treatment.
Many studies, undertaken to observe the relationship between cancer and the consumption of antioxidant vitamins have shown that cancer patients have very low blood levels of antioxidant vitamins. The result of this antioxidant vitamins deficiency also provides additional clues to how and why these nutrients prevent cancer.
Antioxidant vitamins deficiency can:
The first two points underline antioxidant vitamins' importance to cancer immunity. The third point tells us that antioxidant vitamins are needed to block the effect of tobacco smoke in the lungs. The fourth point is especially important to the betacarotene cancer connection. Vitamin A is required normally for the proper growth and differentiation of all epithelial tissues. The changes that can occur in these tissues, when antioxidant vitamins are low or absent, may presage cancer. Epithelial cancers make up more than half the total cancers in men and women, and occur at a wide variety of sites in the body: skin, larynx, esophagus, cervix, colon, rectum, stomach, bladder, kidney, thyroid, breast, uterus, gall bladder, and prostate. These are many of the same cancers shown in population studies to be prevented by a healthy intake of antioxidant vitamins.
Antioxidant vitamins have proven to be able to prevent chemical and spontaneous carcinogenesis in the epithelial tissue of the bronchi, trachea, stomach, skin, uterus, and prostate in man and in animals, both in vitro and in vivo. Various mechanisms have been suggested to explain these anticarcinogenic effects, and epidemiologic studies are currently testing the relationship between retinoid/carotenoid and cancer, in cancer patents and matched controls.
For several years, both the National Cancer Institute and the American Cancer Society have been recommending the use of betacarotene, vitamin A, and vitamin C supplement as a means for cancer prevention. Recent research suggest that antioxidant vitamins inhibit the cancer-causing action of tumor promoters and tumor initiators. Furthermore, in laboratory experiments, betacarotene, vitamin C, and vitamin E have been shown to transform cancer cells to cells that resemble normal cells.
The effect has been noted with tumors such as lung cancer, prostate cancer, colon cancer, and neuroblastoma (a tumor of embryonic nerve cells). In a German study published in Nutritional Abstracts and Reviews, 218 cancer patients received large amounts of antioxidant vitamins for approximately three to seven months. Tumor growth generally stopped or regressed with no side effects.
Recent discoveries about antioxidant vitamins have caused great optimism in the search for allies in the fight against cancer. No other single nutrient has excited cancer scientists quite as much. Due to their free radical scavenging effect, it is believed that antioxidant vitamins enable the body to convert carcinogens to non-toxic derivations which are eliminated in the urine and, consequently, ameliorate the effects of smoking exposure to the body. Consequently, there is little scientific doubt that the establishment and maintenance of effective levels of antioxidant vitamins in the human body yield important health advantages.
The determination of quantitative daily human requirements for antioxidant vitamins could be made if it were possible to correlate known nutrient intake with specific biological responses in precisely controlled studies. Research has also indicated that the taking of larger amounts of antioxidants than the official Recommended Daily Allowance (RDA) builds a stronger protection against free radicals. This larger amount has been suggested to as:
Though the benefits of antioxidant vitamins is well documented, methods of delivering the vitamins to the respiratory area of a patient have been far from superior. Thus, what is needed in the art is method for dispensing antioxidant vitamins within a patient which will allow for maximum benefits from such antioxidant vitamins for therapeutic treatment of diseases of the respiratory tract. It is therefore, to the effective resolution of the aforementioned problems and shortcomings that the present invention is directed.